CSL Behring today presented Phase I data of their recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) in healthy volunteers at the International Society on Thrombosis and Haemostasis (ISTH) congress in Amsterdam.
CSL Behring, in collaboration with its parent company, CSL Limited (ASX: CSL), is developing rVIIa-FP, a novel therapy to treat hemophilia A and hemophilia B patients who have inhibitors (antibodies that develop in response to treatment with other clotting factors that prevents those treatments from working) as part of the PROLONG 7- FP clinical study program. The objective of the clinical program is to demonstrate that an extended half-life rVIIa-FP will result in a requirement for fewer doses while providing adequate therapeutic response in patients with hemophilia A and B with inhibitors.
"Our goal is to pioneer therapeutic solutions that address real unmet needs in the hemophilia community," said Dr. Debra Bensen-Kennedy, Global Therapeutic Head of Clinical Research and Development at CSL Behring. "With our recombinant albumin fusion technology, we believe we have an innovative and promising approach that may yield long-acting therapies with the potential to truly advance hemophilia treatment."
The study enrolled a total of 40 healthy male volunteers between 18 and 35 years of age, who were dosed in five consecutive dose cohorts (140, 300, 500, 750 and 1000 microgram /kg). In each cohort, six participants were randomized to a single dose of rVIIa-FP and two to placebo. All participants received anticoagulation with oral vitamin K antagonist to reach an international normalized ratio (INR) between 2 and 3 prior to dosing with rVIIa-FP or placebo.
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